(ZY-518) Regulatory Affairs AssociatePubblicato il 27-03-2020 - Synteract in Roma Provincia
Regulatory Affairs Associate - Italy
Who We Are
Synteract is a global full-service contract research organization with a successful three-decade track record supporting biotechnology, medical device and pharmaceutical companies. With our mission of ”Bringing Clinical Trials to Life,” we provide customized Phase I through IV services internationally, offering expertise across multiple therapeutic areas including notable depth in Oncology, Neuro Degenerative Diseases, and Rare and Orphan Diseases, and in pediatric populations. Our mission is to support the innovation and development of better therapies in healthcare.
The Regulatory Affairs Associate performs submissions to Regulatory Authorities and Ethics Committees. S/he reviews and compiles the documentation on behalf of the Company’s clients to the standards of ICH/GCP, applicable local requirements, laws and regulations and applicable SOPs. S/he can represent Regulatory Affairs on project teams both internally and externally and helps to coordinate associated activities. Additionally, s/he can help identify the need for Regulatory Affairs standard operating procedures (SOPs), guidelines/work instructions, and can assist with their preparation.
Specific Tasks Would Include
- Provides operations, publishing and submissions support for company’s projects.
- Assists in the management of established timelines to achieve client deliverables on time/within budget.
- Provides oversight to ensure that clinical trials applications (CTAs) are conducted according to local/international requirements/procedures (e.g., ICH-GCP and applicable local law, guidelines, and SOPs).
- Performs submission processes including document editing, publishing, assembly, quality review, and tracking to ensure the planned regulatory submissions (e.g., INDs and CTAs) are of high quality/completed in a timely manner.
- Compiles submission packages and dossiers (e.g., for INDs and CTAs) and reviews all documents required for submissions to ECs (ex-US), and Regulatory Authorities.
- May contribute to the writing/editing of regulatory/technical documents according to applicable regulatory requirements, as appropriate, (e.g., Common Technical Document (CTD), Investigational Medicinal Product Dossier (IMPD), product labeling, and patient information.
- Following management and/or sponsor approval, submits the applications to the relevant ECs or Regulatory Authorities and institutions and tracks submissions until final decision to ensure regulatory submissions are of high quality/completed in a timely manner.
- Serves as interface between regulatory authorities, ECs (ex-US) and the sponsor/client.
- Assists operational staff in forwarding the corresponding documents for the investigator file and forwarding essential documents to the TMF for filing.
- Provides problem resolution in response to questions or concerns from Clinical Operations/study sites with regard to regulatory issues.
- Provides support for clinicaltrials.gov registration/reporting.
- May serve as regulatory lead for clinical trials.
- Helps prepare for, and can participate in, client audits and regulatory authority inspections.
- Contributes to the company’s Regulatory Intelligence database, as needed.
- Arranges translation of regulatory documents, if required.
- Attends project team meetings, if needed.
- Degree in life sciences (Bachelor’s degree in US) or relevant/related field preferred. 1 year of experience or more in clinical research/regulatory procedures is an asset.
- Knowledge of local, national and international laws, regulations and guidelines for medicinal products and their development applicable in his/her respective region.
- Knowledge of clinical and/or pharmaceutical-technological drug development.
- Familiarity with medical terminology
- Experience with current CTD/eCTD regulations and requirements in accordance with IDE/IND/CTA/NDA/MAA and global specifications and publishing tools are an asset.
- Knowledge of local, national and international laws, regulations and guidelines applicable for medical devices and their development in his/her respective region is an asset.
- Intermediate proficiency in Microsoft Word, Excel, PowerPoint, and Adobe Acrobat and the ability to use Outlook and the Internet.
- Effective verbal and writing skills: English + Italian
If you’re passionate about bringing clinical trials to life, we encourage you to apply today!
Synteract’s policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Candidates must possess current and valid authorization to work in the country to which they are applying.